Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies

Novartis

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: TKI258

Study type: Interventional

Funder types: Industry

Identifiers

NCT00669097

CTKI258A2106

Details and patient eligibility

About

This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥ 18 years
2. Patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available.
3. WHO performance status ≤ 2
4. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have been resolved
5. Written informed consent to participate in the study

Exclusion criteria

1. Primary Brain Tumors or symptomatic leptomeningeal metastases
2. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
3. Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection Pregnant or lactating women (all women of childbearing potential must have a negative pregnancy test (> 5 mIU/ml) before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection
4. Centrally located or squamous cell carcinoma of the lung
5. Proteinuria > 1+ on dipstick testing
6. History of gastrointestinal malabsorption Surgery involving intestinal anastomosis within four weeks of study start.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

TKI258

Experimental group

Treatment:

Drug: TKI258